LOCALLY ADVANCED (STAGE III AND IV) HEAD AND NECK CANCER: WESTMEAD HOSPITAL EXPERIENCE

BACKGROUND As most cases of head and neck cancer are locally advanced, i.e., stage III and IV, it may be useful to compare induction chemotherapy policies accompanied by simultaneous chemoradiation with concomitant chemoradiation alone, in terms of tumour response and toxicity profile in these cases. That's why this study was undertaken. We wanted to evaluate induction chemotherapy accompanied by chemoradiation in terms of local regulation as opposed to chemoradiation alone in locally advanced Head and Neck Cancers. METHODS This is a prospective comparative study. Study was done between July 2017 and July 2019, with Arm A (Test Group) & Arm B (Control group). Forty patients of locally advanced Head and Neck cancer from the outpatient department, selected for treatment, were included in the study, with 20 in each arm. RESULTS Reduction in tumour size after treatment was compared in both the groups with RECIST (Response Evaluation Criteria in Solid Tumours) 1.1. Induction chemotherapy caused significant reduction in tumour size but had more toxicities which were manageable. When compared to conventional chemoradiation, the induction chemo group did not show statistically significant benefit. Response was better in patients with high nodal volume as some of the cases showed good response in the nodal volume irrespective of response of the primary. CONCLUSIONS This study emphasizes the role of induction chemotherapy in select patients with advanced disease, especially in high volume, where majority of cases (more than 80 %) are stage III or IV and above. Hence, patient selection is the key to outweigh the risk involved. KEYWORDS Cancer Undergoing Radiation Therapy

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Randomised phase-III-trial of concurrent chemoradiation (CRT) for locally advanced head and neck cancer (stage III-IVB): Comparing dose reduced radiotherapy (63,6 Gy) with paclitaxel/cisplatinum to standard radiotherapy (70,6 Gy) with fluorouracil/cisplatinum.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.6016 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 6016-6016 ◽

Cited By ~ 3

Author(s):

Rainer Fietkau ◽

Heinrich Iro ◽

Markus Hecht ◽

Benjamin Hofner ◽

Olaf Gefeller ◽

...

Keyword(s):

Head And Neck Cancer ◽

Head And Neck ◽

Neck Cancer ◽

Locally Advanced ◽

Distant Metastases ◽

Phase Iii ◽

Stage Iii ◽

Advanced Head ◽

Hpv Status ◽

Intensified Chemotherapy

6016 Background: Concurrent CRT with 70.6 Gy is the standard treatment for locally advanced head and neck cancer (LA-SCCHN). There exist no prospective data on safety and efficacy of a reduced radiation (RT) dose. Methods: Pts with stage III-IVB LA-SCCHN were randomized 1:1 to receive 70.6 Gy with concurrent cisplatinum (20mg/m²/d IV on days 1-5 and 29-33) and fluorouracil (600 mg/m²/d CIV on days 1-5 and 29-33) (standard arm A) versus 63,6 Gy with intensified chemotherapy using concurrent cisplatinum (20mg/m²/d IV on days 1-4 and 29-32) and paclitaxel (20mg/m²/d IV on days 2, 5, 8, 11 and 25, 30, 33, 36) (experimental arm B). After a planned interim analysis recruitment was stopped due to statistical reasons. Results: Between 06/2010 and 02/2015 a total of 221 pts were randomized with 105 pts receiving treatment in arm A and 112 in arm B (4 pts dropped out). Median follow-up was 38 months. Pts’ characteristics: Oral cavity (15%), oropharynx (54%), hypopharynx (28%), larynx (14%); 17 pts had more than one primary site; tumor stage: III (14%), IV (86%); HPV-status (p16) was positive in 20%, negative in 38%, currently pending in 42%. A total of 96 PFS-related events occurred. 3-year PFS (ITT) was 58% in the standard arm A and 48% in experimental arm B (p = 0.454). 3-year OS (ITT) was 64% in arm A and 59% in arm B (p = 0.688). 3-year rates of distant metastases, loco-regional recurrences and death were 10% vs 12%, 17% vs 21% and 15% vs 19% for pts in arm A and B, respectively. As for the p16-positive subgroup, 3-year PFS/OS were 77%/76% in arm A (n = 21) and 69%/80% in arm B (n = 22), respectively. Grade 3+ hematologic adverse events during therapy (arm A/arm B): Anemia 11%/4% (p = 0.038); neutropenia 40%/16% (p < 0.001); thrombocytopenia 8%/3% (p = 0.130). Conclusions: These preliminary results indicate that pts receiving concurrent CRT for LA-SCCHN did not benefit from a lower total RT dose of 63.6Gy despite intensified chemotherapy. However, in the subgroup of p16-positive pts a reduced RT dose may be sufficiently effective. Clinical trial information: NCT01126216.

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